Digital Transformation Project Manager Team Horizon is seeking a Digital Transformation Project Manager for a client in Mayo. This role oversees a portfolio of digital transformation initiatives designed to enhance operational efficiency, optimize manufacturing processes, and drive a culture of innovation and excellence. The ideal candidate brings a strong understanding of digital technologies, project management methodologies, and the biopharmaceutical industry, with the ability to translate strategy into impactful execution. Why you should apply: Contribute your passion and expertise in digital transformation to impact the future of manufacturing and set new standards for operational excellence. You will play a key role in my clients digital transformation journey. Youll work in a dynamic, collaborative environment where your ideas are valued, your voice matters, and your expertise directly shapes the future of the organisation. Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work. What you will be doing: Coordinate a portfolio of digital transformation projects, liaising with above-site teams and SMEs to represent the Westport site. Collaborate with leadership to develop and implement digital strategies supporting operational and business goals. Collaborate with cross-functional teams, including IT, operations, regulatory affairs, and quality assurance, to gather requirements and ensure alignment of project goals. Drive value analysis and business case development for both new and existing digitalization projects Communicate project status, risks, and milestones to stakeholders at various levels. Develop and implement change management strategies to ensure broad user acceptance and successful adoption of initiatives. Represent the Business/Site in the deployment of digital tools and technologies, including system architecture and configuration discussions, acting as the operations/business voice in technical forums. Lead cross-functional teams in project delivery, ensuring projects are completed on time, within scope, and with clear stakeholder engagement. Establish and monitor KPIs to measure the success and performance of digital transformation initiatives. Ensure all initiatives comply with relevant regulations and standards. What you need to apply: Bachelors degree in Business Administration, Information Technology, Engineering, or a related field. Proven experience in digital transformation and project management, preferably in a manufacturing or biopharmaceutical environment. Experience in Lean, Six Sigma, or other process improvement methodologies. Knowledge of or strong interest in digitalization, technology, and operational excellence principles (e.g., IoT, AI, robotics). Excellent project and portfolio management skills, with the ability to multitask and manage cross-functional resources. Strong communication, analytical, and problem-solving skills; demonstrated ability to influence stakeholders at all levels. Preferred qualifications Masters degree in a related area is advantageous. Certifications such as Lean Six Sigma Black Belt, PMP, or credentials related to Industry 4.0. Experience with Industry 4.0 technologies and leading digital manufacturing projects. Skills: financial acumen Change Management Digital Transformation Project Management EBR IT Engineering
Senior Delta V Engineer Team Horizon is seeking a Senior Delta V Engineer for a client in Sligo who will support multiple projects Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Designing, coding, and testing DeltaV software changes identified during all stages of the project lifecycle. Working with a range of other automation related systems such as PLC and DCS systems and others You will contribute to technical strategy for the execution of Automated projects and review all work during the design, commissioning, and validations stage. Supporting from design to handover. Communicating and collaborating at a variety of levels. What you need to apply: Candidates must have a B.Sc. degree in Engineering or equivalent, with emphasis in software development, electrical, electronic or automation discipline, with a minimum of 5 years experience in industry, preferably in a pharmaceutical, biotechnology, blue chip or relevant GMP manufacturing environment Significant experience working with DeltaV distributed controls systems Emerson Process Management DeltaV Platform experience as well as knowledge and experience in Batch Processing Ideally you will have been trained in the Emerson inhouse DeltaV training house At least 5 years experience with Automation systems administration, knowledge in one or more of the following systems, Rockwell Factory Talk, DCS, OSI PI Historian, Syncade, Siemens is essential. Knowledge of S88 Demonstrated proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills In addition to problem solving, project management ability is essential Ability to work independently and remotely with minimum direct supervision Strong Customer relationship management skills Strong Critical thinking skills. The ideal candidate will have excellent communication skills and strong problem skills. Candidates trained in house on DeltaV with Emersons dedicated DeltaV training center will be given preference. Skills: Delta V rockwell Syncade Siemens Customer Relationship Management GMP
Team Horizon is seeking a Site Process and Cleaning Validation Lead for a world-class, innovation-driven pharmaceutical manufacturing site. This role offers the opportunity to lead critical validation activities at a high-performing, globally regulated facility, working with advanced technologies and strong quality systems. The successful candidate will provide hands-on technical leadership across process and cleaning validation while influencing cross-functional teams, supporting audits, and driving continuous improvement in a patient-focused environment. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Develop and implement site-wide master plans for process and cleaning validation activities. Lead the development, planning, and execution of validation strategies and PPQ protocols, including risk assessments, data evaluation, and technology transfer support. Oversee the review, approval, and maintenance of validation documentation, reports, and change control records. Partner cross-functionally with manufacturing, engineering, and quality teams to support continuous improvement initiatives. Ensure full compliance with global regulatory standards (e.g., FDA, EMA) and internal quality policies. Manage validation-related investigations, deviations, and the implementation of corrective and preventive actions (CAPAs). Deliver training to site personnel on validation processes, expectations, and best practices. Serve as the validation representative during internal audits, external audits, and regulatory inspections. Participate in risk assessments and design reviews across all business units. Track, analyze, and report weekly performance metrics (e.g., GTW, QMS, EHS, ComplianceWire). Support audit readiness activities, actively engage during audits, and contribute to audit responses and follow-up actions, including participation in internal and external audit programs. Manage revalidation schedules, regulatory response support, laboratory validation document reviews, and APR reporting in collaboration with business unit owners. Coach, develop, and upskill direct reports to ensure strong technical capability and leadership support at the site level. Lead, motivate, and communicate effectively with team members and management to drive engagement and performance. Conduct performance evaluations in line with company policies, including individual development planning. Maintain appropriate staffing levels aligned with business needs, including recruitment and selection. Develop and manage departmental budgets to achieve organizational objectives. Address underperforming KPIs by implementing robust and sustainable preventive action plans. What you need to apply: Minimum of 9+ years of experience with a Bachelors degree, 7+ years with a Masters degree, or 5+ years with a PhD in a scientific or engineering discipline (e.g., Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field). At least 7+ years of hands-on experience in pharmaceutical validation, including process and/or cleaning validation. Strong working knowledge of validation-related regulatory requirements and guidelines (cGMP, FDA, EMA, ICH Q7, Q8, Q9, Q10). Demonstrated strengths in project management, problem-solving, and organizational skills. Proven ability to work effectively in cross-functional teams while managing multiple priorities and projects. Excellent conflict resolution and stakeholder management skills. Subject matter expertise in key validation areas such as cleaning validation, CSV, aseptic processing, process validation, and CPV. Solid understanding of process validation, computer system validation, SCADA systems, continued process verification (CPV), sterilization, packaging systems, and associated technologies. Strong awareness of current data integrity expectations is highly desirable. Excellent written and verbal communication and presentation skills, with the ability to clearly and concisely present data to team members and senior management when required. Skills: Cleaning Validaton process validation validation Leadership NPI Benefits: Performance Bonus Medical Aid / Health Care Pension Fund
A leading company in the pharmaceutical industry is seeking a Head of Quality in Leinster, Ireland. You will oversee Quality Assurance and Quality Control teams, ensuring compliance and optimizing operations. The ideal candidate has over 5 years of experience in pharmaceutical quality management and is eligible to be named as a Qualified Person. A highly competitive salary and benefits package are offered. #J-18808-Ljbffr
Social network you want to login/join with: Team Horizon - Head of Quality Location: Midlands, UK Team Horizon is seeking a Head of Quality for our client's manufacturing facility in the Midlands. In this role, you will oversee the Quality Assurance and Quality Control Teams, support the implementation, maintenance, and continual improvement of the company's QMS, and undertake the role of QP named on the relevant MIA(s). Why you should apply: Opportunity to work with a diversified portfolio of products across multiple therapeutic areas, including analgesics and anti-infectives. Excellent chance to utilise QP eligibility and leadership experience in a Head of QA position overseeing Quality Assurance and Quality Control Teams. Highly competitive salary and benefits package. Key responsibilities: Ensure an appropriate, compliant QMS is in place to meet site compliance, including regulator inspections, and optimize throughput. Perform QP certification of products for market release, in line with business needs and schedule. Manage site quality operations and batch certification activities, ensuring compliance and timely release. Review batch documentation and certify products in accordance with GMP, MA, and legislation. Communicate issues impacting release to management and supply chain. Promote GMP, GDP, and QMS practices within the site, seeking continuous improvement. Support investigations into non-conformances, complaints, recalls, and batch issues. Review and approve QMS documentation related to quality activities. Establish and monitor KPIs for quality activities and oversee site audit programs. Coordinate complaint management and recalls. Prepare for and support regulatory, company, and customer audits. Implement and oversee training programs on QMS processes and SOPs. Participate in management reviews and maintain accurate records of authorized activities. Stay informed of applicable legislation and industry practices. Perform additional tasks as assigned. Qualifications: Eligible to be named on a manufacturing license as a Qualified Person under EU Directive 83/EC or amendments. Minimum of 5 years' experience in pharmaceutical quality management. Strong organizational, communication, and project management skills, with proficiency in IT. This job is active and accepting applications. #J-18808-Ljbffr
